I took Dr Collins class “Biomaterials” last spring, and this discussion took me back to a discussion we had in class about the Global Regulatory Environment.
The FDA has very stringent rules, that they are adamant into applying. Whereas other countries in the world do not have such strict guidelines for drug/medical device distributions. So companies that we’re able to receive FDA approval on their drugs/devices would out source them to countries that lack strict policies.
I think that every country should have a unanimous policy where as, if the drug/medical has not received approval from their respective countries they shouldn’t be allowed to be distributed.